Trial Outcomes & Findings for A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter (NCT NCT05373862)
NCT ID: NCT05373862
Last Updated: 2025-03-03
Results Overview
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 7 days of index procedure on Day 1
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
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|---|---|
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Overall Study
STARTED
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40
|
|
Overall Study
COMPLETED
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40
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
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|---|---|
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Age, Continuous
|
58.0 years
STANDARD_DEVIATION 15.73 • n=40 Participants
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Sex: Female, Male
Female
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15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days of index procedure on Day 1Population: Per-protocol analysis set included all participants who completed the protocol-required "pre-ablation mapping" with the investigational catheter.
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
|
40 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days of index procedure on Day 1Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
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|---|---|
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Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
|
1 Participants
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SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for maneuverability \& handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
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|---|---|
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Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 6
|
14 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Atrium): Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Atrium): Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Left Ventricle): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Deploy (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 5
|
8 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Atrium): Score 7
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Atrium): Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 6
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Left Ventricle): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Maneuver (Right Ventricle): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 6
|
11 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Atrium): Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 6
|
8 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Atrium): Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 6
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Left Ventricle): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to Reach Areas (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Atrium): Score 7
|
10 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Atrium): Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Left Ventricles): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Ability to withdraw (Right Ventricles): Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 5
|
11 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 6
|
20 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Overall ease of use of the catheter: Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Insertion and withdrawal from introducer sheath: Score 7
|
12 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 5
|
12 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 6
|
17 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability and Handling
Learning curve: Score 7
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=38 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 6
|
5 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atria: Score 7
|
6 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 6
|
2 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricles: Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 5
|
6 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 6
|
11 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 7
|
6 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 5
|
6 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atria: Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 6
|
2 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricles: Score 7
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BASELINE noise encountered: Score 7
|
14 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 7
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=23 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
High output stimulation pacing: Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 3
|
2 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 7
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 5
|
11 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 6
|
22 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Ability to achieve electrode contact with cardiac tissue: Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrodes spacing: Score 7
|
13 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 6
|
18 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design
Electrode array coverage: Score 7
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 5
|
11 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 7
|
5 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 3
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 5
|
14 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 7
|
10 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 5
|
14 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 6
|
19 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 5
|
8 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 6
|
11 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 7
|
12 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 1
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 6
|
18 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 2
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 3
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 7
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 3
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 7
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 1
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 1
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 5
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 7
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 1
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 1
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 4
|
7 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 6
|
16 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
CARTO 3 System: Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Electrophysiology (EP) Lab recording equipment: Score 1
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 3
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 5
|
16 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 6
|
11 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 5
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 4
|
6 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 7
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Implantable cardioverter-defibrillators (ICD) or other implantable devices: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 7
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 6
|
20 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters: Score 7
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=30 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 5
|
8 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to the PENTARAY catheter: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 6
|
6 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Compared to other competitive multielectrode catheters: Score 7
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 4
|
8 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 5
|
10 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 6
|
17 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter: Score 7
|
7 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters: Score 1
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 5
|
14 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 5
|
14 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 6
|
18 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to the PENTARAY catheter: Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Compared to other competitive multielectrode catheters: Score 7
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days of index procedure on Day 1Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days of index procedure on Day 1Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.
Outcome measures
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter
|
1 Participants
|
Adverse Events
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 participants at risk
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Cardiac disorders
Atrioventricular block
|
2.5%
1/40 • Number of events 1 • From screening up to 29 weeks
The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
|
|
Cardiac disorders
Cardiac tamponade
|
2.5%
1/40 • Number of events 1 • From screening up to 29 weeks
The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1 • From screening up to 29 weeks
The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
|
|
Cardiac disorders
Transient complete atrioventricular block
|
2.5%
1/40 • Number of events 1 • From screening up to 29 weeks
The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
|
Other adverse events
| Measure |
Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter)
n=40 participants at risk
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure.
|
|---|---|
|
Cardiac disorders
Transient right bundle branch block
|
2.5%
1/40 • Number of events 1 • From screening up to 29 weeks
The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
|
Additional Information
Senior Director Clinical Research
Biosense Webster, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publications and/or presentation of clinical investigation results will be coordinated and governed between Biosense Webster, Inc., the clinical investigation author(s) and if applicable local law. Authorship will be determined prior to development of any manuscript.
- Publication restrictions are in place
Restriction type: OTHER